Zambia

v. 28 – Q4 2023

Market Executive Summary Based on the legal mandate to “enforce a ‘suitable coding’ system for all medicines meant for the Zambian market as part of ‘Product Labelling and Packaging Requirements’”, the Zambia Medicines Regulatory Agency (ZAMBRA) has published official guideline on traceability of medicines.

The ZAMBRA requirements are fully aligned with GS1 standards and mandate:
Labelling/Barcoding

  • At secondary pack level: 4-element GS1 DataMatrix with GTIN, expiry date, Lot/Batch and serial number
  • At higher level of packaging: SSCC
  • At primary pack level: GS1 DataMatrix for product identification purposes (assuming GTIN)

The requirements are time-phase (see “Key Dates”).

Note that even though the guidance includes the requirement of applying serial numbers at secondary pack level, there is as yet no indication of the establishment of any system or reporting of serialisation / traceability data.

Master Data Provision
Requirement to provide and submit master data to identify organisations (MAH, Manufacturing Site, Legal Entity) and trade items (list of 13 mandatory and 52 optional attributes), timeline see “Key Dates”).

Initially this will be done using the ZAMRA “Product and Location Master Data Submission Form” (excel format) but the plan is to move to electronic submission using the GS1 GDSN mechanism (no timeline or forther details announced).

Key Dates Dates below are derived from the date of official publication of the traceability guideline (August 2023).

Labelling/Barcoding

  • GTIN
    • Imported Medicines: August 2025
    • Domestically Manufactured Medicines: August 2026
  • Exp and Lot
    • Imported Medicines: August 2025
    • Domestically Manufactured Medicines: August 2026
  • Serial Number
    • Imported Medicines: August 2028
    • Domestically Manufactured Medicines: August 2028

Master Data Provision
Requirement to provide and submit master data to

  • Identify organisations (MAH, Manufacturing Site, Legal Entity) at the point of MA application
  • Trade items: February 2025 (1.5 years after publication of the traceability guideline)

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